Clotrimazole 1%
Clotrimazole USP, 1% Athlete's Foot
9aba1345-ef47-4951-8448-a43d6696b616
HUMAN OTC DRUG LABEL
Jul 7, 2025
STRATEGIC SOURCING SERVICES LLC
DUNS: 116956644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Foster & Thrive™
Athlete's Foot Cream
Clotrimazole Cream USP, 1%
ANTIFUNGAL
NET WT 1 OZ (30 g)
INDICATIONS & USAGE SECTION
Uses
- cures most athlete's foot, jock itch and ringworm
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
SPL UNCLASSIFIED SECTION
**Distributed by:**McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Clotrimazole 1%
OTC - PURPOSE SECTION
Purpose
Antifungal
WARNINGS SECTION
Warnings
For external use only
Do not useon children under 2 years of age unless directed by a doctor.
When using this productavoid contact with the eyes.
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- wash affected area and dry thoroughly
- apply a thin layer over affected area twice daily (morning and night)
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- if condition persists longer, ask a doctor
- this product is not effective on the scalp or nails
STORAGE AND HANDLING SECTION
Other information
*TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
- to open: unscrew cap, use the pointed end of cap to puncture seal.
- store between 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
OTC - QUESTIONS SECTION
Questions?
call833-358-6431